Kelly Services Director, Regulatory Affairs in Schaumburg, Illinois
Job Title: Director, Regulatory Affairs
Location: Schaumburg, IL (onsite)
To develop, lead and execute the corporation’s regulatory compliance strategy including Drugs and Medical devices. To ensure complete compliance with all FDA, QSR, cGMP, and other federal and state regulations, and with corresponding international regulations in all markets served. The scope of this position impacts all products (device, drug, food, supplement) in all life-cycle phases (design planning, manufacturing or subcontracting, post-market surveillance), and services (marketing communications, order acceptance and fulfillment) that affect customer satisfaction in all channels of trade.
Essential Job Functions:
To provide leadership for the Regulatory Affairs function at all SAI facilities.
To ensure compliance with international GMPs, US FDA regulations, etc. in all countries of manufacture and exportation.
To serve as the Official Contact with FDA and related regulatory authorities at the federal, state local and international level.
To work with executive management and aid in determination of extraordinary matters (recalls, market withdrawals, regulatory matters, compliance issues, etc.).
To ensure timely regulatory filings for the company (device listings, establishment registrations, MedWatch filings, adverse event reporting, etc.). Responsible for establishment and maintenance of filing procedures, tracking, re-certification, etc.
To serve as consultant and advisor for new products, facilitating the timely introduction of safe and effective new products while ensuring that all customer and regulatory requirements are researched and communicated to the design team, are subsequently met prior to launch, and are monitored for compliance in the production and post-market phases,
To ensure international market growth by providing the technical, quality and regulatory documents that are required to register products in each country.
To continually monitor the effectiveness of the production and business processes that impact customer satisfaction (innovation, marketing communication, order fulfillment, purchasing and manufacturing), to develop, lead and execute corporate strategy aimed at maximizing the results of those processes, and to report progress to the corporate Officers globally.
To thoroughly research all guidance (ICH, FDA, QSR, etc.) related to regulatory matters, and report on same to the appropriate personnel.
To educate corporately on areas of responsibility as appropriate. Provide training (or training direction) necessary and increase knowledge corporation-wide of RA guidelines.
To hire, train, motivate, evaluate and develop direct and indirect reports for optimum performance and compliance. Evaluate department structure for maximum efficiency.
To provide as-needed, guidance to parent company subsidiaries (i.e., Canada, Latin America, and EMEA) regarding regulatory issues.
Education, Knowledge, Skills, and Abilities:
Bachelor’s degree in sciences or Engineering is required.
Advanced degree in science or business management is preferred.
At least 10 years in a significant corporate regulatory within an FDA-regulated drugs and devices industry with 8 years demonstrated leadership
Comprehensive knowledge of FDA, cGMP (mandatory).
Well versed with 21 CFR 803 (Medical Device Regulations)
Experience with international GMP/RA compliance requirements, especially EMEA, Latin America and Canada.
Proven record for exceeding quality and business goals
Thorough understanding and working knowledge of 510(k) & PMA submissions, and ANDAs
Outstanding leadership skills
Expertise to command regulatory compliance activity in alignment with corporate policies and industry regulations
Computer proficiency: Microsoft Office
Strong organizational and time management skills – high attention to detail
Self-starter with strong interpersonal skills
Communication skills: Written, Oral and Presentation
Ability to direct cross functional resources in a fast-paced work environment
Ability to interpret and accommodate legislation
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.